BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 1030784 · Received April 17, 2008

    Report

    Report Number
    2210968-2008-00254
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 19, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (DAMAGE TO DRIVE CONNECTOR/COUPLING)- THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVAL. USING A DISPOSABLE HAND PIECE, THE UNIT RAN FOR TEN MINUTES CLOCKWISE AND TEN MINUTES COUNTER-CLOCKWISE WITHOUT THE BLADE STOPPING OR OTHER PROBLEMS. THE INTERNAL INSPECTION REVEALED NO LOOSE HARDWARE OR ELECTRICAL CONNECTIONS. FULL PERFORMANCE VERIFICATION CONFIRMED THAT UNIT PERFORMED PER REQUIREMENT. IN ADDITION, A REVIEW OF THE DEVICE MFG RECORDS WAS CONDUCTED, AND THE DEVICE MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A GYNECOLOGICAL PROCEDURE IN 2008. DURING THE PROCEDURE, THE DISPOSABLE HAND PIECE BOUND UP WHEN ATTACHED, BUT WHEN THE DISCONNECT ON THE CPC CONNECTOR WAS PRESSED, THE DEVICE WORKED CORRECTLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE WITH NO ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE X-TRACT MORCELLATOR LAPAROSCOPIC MORCELLATOR HET ETHICON, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK